Oxeltra 20mg Prolonged-Release Tablets
106745/2
Package leaflet: Information for the user
Oxeltra 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg,
60 mg and 80 mg Prolonged-Release Tablets
Oxycodone hydrochloride
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Oxeltra tablets are and what they are used for
2. What you need to know before you take Oxeltra tablets
3. How to take Oxeltra tablets
4. Possible side effects
5. How to store Oxeltra tablets
6. Contents of the pack and other information
1. What Oxeltra tablets are and what they are used for
These tablets have been prescribed for you by your doctor to relieve moderate to severe pain over a period of 12 hours. They contain the active ingredient oxycodone which belongs to a group of medicines called strong analgesics or 'painkillers'
2. What you need to know before you take Oxeltra tablets
Do not take Oxeltra tablets if you:
• are allergic (hypersensitive) to oxycodone, or any of the other ingredients of the tablets (listed in section 6);
• have breathing problems, such as severe chronic obstructive airways disease, severe bronchial asthma or severe respiratory depression. Your doctor will have told you if you have any of these conditions. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected;
• have a condition where the small bowel does not work properly (paralytic ileus), your stomach empties more slowly than it should (delayed gastric emptying) or you have severe pain in your abdomen;
• have a heart problem after long-term lung disease (cor pulmonale);
• have moderate to severe liver problems. If you have other long-term liver problems you should only take these tablets if recommended by your doctor;
• have ongoing problems with constipation;
• are under 18 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Oxeltra tablets
if you:
• are elderly and weakened;
• have an under-active thyroid gland (hypothyroidism), as you may need a lower dose;
• have myxoedema (a thyroid disorder with dryness, coldness and swelling ('puffinessO of the skin affecting the face and limbs);
• have a head injury, severe headache or feel sick as this may indicate that the pressure in your skull is increased;
• have low blood pressure (hypotension);
• have low blood volume (hypovolaemia); this can happen with severe external or internal bleeding, severe burns, excessive sweating, severe diarrhoea or vomiting;
• have a mental disorder as a result of an infection (toxic psychosis);
• have inflammation of the pancreas (which causes severe pain in the abdomen and back);
• have problems with your gall bladder or bile duct;
• have inflammatory bowel disorders;
• have an enlarged prostate gland, which causes difficulty in passing urine (in men);
• have poor adrenal gland function (your adrenal gland is not working properly which may cause symptoms including weakness, weight loss, dizziness, feeling or being sick), e.g. Addison's disease;
• have breathing problems such as severe pulmonary disease. Your doctor will have told you if you have this condition. Symptoms may include breathlessness and coughing;
• have liver or kidney problems;
• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, upon stopping taking alcohol or drugs;
• are or have ever been addicted to alcohol or drugs or have a known opioid dependence;
• have an increased sensitivity to pain;
• need to take increasingly higher doses of Oxeltra to gain the same level of pain relief (tolerance).
If you are going to have an operation, please tell the doctor at the hospital that you are taking these tablets.
Other medicines and Oxeltra tablets
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you take these tablets with some other medicines, the effect of these tablets or the other medicine may be changed.
Tell your doctor or pharmacist if you are taking:
• a type of medicine known as monoamine oxidase inhibitor or you have taken this type of medicine in the last two weeks;
• medicines to help you sleep or stay calm (for example tranquillisers, hypnotics or sedatives);
• medicines to treat depression (such as paroxetine);
• medicines to treat psychiatric or mental disorders (such as
phenothiazines or neuroleptic drugs);
• other strong analgesics or painkillers;
• muscle relaxants;
• medicines to treat high blood pressure;
• quinidine (a medicine to treat a fast heart beat);
• cimetidine (a medicine for stomach ulcers, indigestion or heartburn);
• antifungal medicines (such as ketoconazole, voriconazole, itraconazole and posaconazole);
• antibiotics (such as clarithromycin, erythromycin or telithromycin);
• medicines known as 'protease inhibitors' to treat HIV (e.g. boceprevir, ritonavir, indinavir, nelfinavir or saquinavir);
• rifampicin (used to treat tuberculosis);
• carbamazepine (used to treat seizures, fits or convulsions);
• phenytoin (used to treat seizures, fits or convulsions);
• a herbal remedy called St John's Wort (also known as Hypericum perforatum);
• antihistamines;
• medicines to treat Parkinson's disease.
Also tell your doctor if you have recently been given an anaesthetic.
Taking Oxeltra tablets with food, drink and alcohol
Drinking alcohol whilst taking Oxeltra tablets may make you feel more sleepy or increase the risk of serious side effects such as shallow breathing with a risk of stopping breathing, and loss of consciousness. It is recommended not to drink alcohol while you're taking Oxeltra tablets.
You should avoid drinking grapefruit juice while you are taking these tablets.
Pregnancy and breastfeeding
Do not take these tablets if you are pregnant or breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
These tablets may cause a number of side effects such as drowsiness which could affect your ability to drive or use machinery (see section 4 for a full list of side effects). These are usually most noticeable when you first start taking the tablets, or when changing to a higher dose. If you are affected you should not drive or use machinery.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
o The medicine has been prescribed to treat a medical or dental problem and
o You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
o It was not affecting your ability to drive safely
There is further information for patients who are intending to drive in Great Britain - go to: http://www.gov.uk/drug-driving-law
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Oxeltra tablets contain lactose
These tablets contain lactose which is a form of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.
3. How to take Oxeltra tablets
Always take these tablets exactly as your doctor has told you. The label on your medicine will tell you how many tablets to take and how often.
Adults (over 18 years of age)
The usual starting dose is one 10 mg tablet every 12 hours. However, your doctor will prescribe the dose required to treat your pain. If you find that you are still in pain whilst taking these tablets, discuss this with your doctor.
Do not exceed the dose recommended by your doctor. You should check with your doctor or pharmacist if you are not sure.
Swallow your tablets whole with water. Do not crush, dissolve or chew them.
Oxeltra tablets are designed to work properly over 12 hours when swallowed whole. If a tablet is broken, crushed, dissolved or chewed, the entire 12-hour dose may be absorbed rapidly into your body. This can be dangerous, causing serious problems such as an overdose, which may be fatal.
You should take your tablets every 12 hours. For instance, if you take a tablet at 8 o'clock in the morning, you should take your next tablet at 8 o'clock in the evening.
You must only take the tablets by mouth. The tablets should never be crushed or injected as this may lead to serious side effects, which may be fatal.
Use in children
Children and adolescents under 18 years of age should not take the tablets.
Patients with kidney or liver problems
Please tell your doctor if you suffer from kidney or liver problems as they may prescribe a lower dose depending on your condition.
106745/2
If you take more Oxeltra tablets than you should or if someone accidentally swallows your tablets
Call your doctor or hospital straight away. People who have taken an overdose may feel very sleepy, sick or dizzy, or have hallucinations. They may also have breathing difficulties leading to unconsciousness or even death and may need emergency treatment in hospital. When seeking medical attention make sure that you take this leaflet and any remaining tablets with you to show to the doctor.
If you forget to take your Oxeltra tablets
If you remember within 4 hours of the time your tablet was due, take your tablet straight away. Take your next tablet at your normal time. If you are more than 4 hours late, please call your doctor or pharmacist for advice. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Oxeltra tablets
You should not suddenly stop taking these tablets unless your doctor tells you to. If you want to stop taking your tablets, discuss this with your doctor first. They will tell you how to do this, usually by reducing the dose gradually so you do not experience unpleasant effects. Withdrawal symptoms such as agitation, anxiety, palpitations, shaking or sweating may occur if you suddenly stop taking these tablets.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, these tablets can cause side effects,
■ although not everybody gets them.
| All medicines can cause allergic reactions, although serious
• allergic reactions are rare. Tell your doctor immediately if you
i get any sudden wheeziness, difficulties in breathing, swelling j of the eyelids, face or lips, rash or itching especially those
• covering your whole body.
The most serious side effect is a condition where you breathe
more slowly or weakly than expected (respiratory depression).
As with all strong painkillers, there is a risk that you may
become addicted or reliant on these tablets.
Other possible side effects
Very common (may affect more than 1 in 10 people):
• constipation (your doctor can prescribe a laxative to overcome this problem)
• feeling or being sick (this should normally wear off after a few days, however your doctor can prescribe an anti-sickness medicine if it continues to be a problem)
• drowsiness (this is most likely when you start taking your medicine or when your dose is increased, but it should wear off after a few days)
• dizziness
• headache
• itchy skin.
Common (may affect up to 1 in 10 people):
• dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhoea
• confusion, depression, a feeling of unusual weakness, shaking, lack of energy, tiredness, anxiety, nervousness, difficulty in sleeping, abnormal thoughts or dreams
• difficulty in breathing or wheezing, shortness of breath, decreased cough reflex
• rash
• sweating.
Uncommon (may affect up to 1 in 100 people):
• difficulty in swallowing, belching, hiccups, wind, a condition where the bowel does not work properly (ileus), inflammation of the stomach, changes in taste
• a feeling of dizziness or 'spinning', hallucinations, mood changes, unpleasant or uncomfortable mood, a feeling of extreme happiness, restlessness, agitation, generally feeling unwell, loss of memory, difficulty in speaking, reduced sensitivity to pain or touch, tingling or numbness, seizures, fits or convulsions, blurred vision, fainting, unusual muscle stiffness or slackness, involuntary muscle contractions.
• difficulty in passing urine, impotence, decreased sexual drive, low levels of sex hormones in the blood ('hypogonadism', seen in a blood test)
• fast, irregular heart beat, flushing of the skin.
• dehydration, thirst, chills, swelling of the hands, ankles or feet.
• dry skin, severe flaking or peeling of the skin.
• redness of the face, reduction in size of the pupils in the eye, muscle spasm, high temperature.
• a need to take increasingly higher doses of this medicine to obtain the same level of pain relief (tolerance).
• colicky abdominal pain or discomfort.
• a worsening of liver function tests (seen in a blood test).
Rare (may affect up to 1 in 1,000 people):
• low blood pressure
• a feeling of 'faintness' especially on standing up
• hives (nettle rash).
Frequency not known (frequency cannot be estimated
from the available data):
• increased sensitivity to pain.
• aggression
• tooth decay
• absence of menstrual periods
• a blockage in the flow of bile from the liver (cholestasis). This can cause itchy skin yellow skin, very dark urine and very pale stools
• long term use of Oxeltra during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Symptoms to look for in the baby include irritability, hyperactivity and abnormal sleep pattern, high pitched cry, shaking, being sick, diarrhoea and not putting on weight.
You may see the remains of the tablets in your faeces. This should not affect how the tablets work.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at http://www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Oxeltra tablets
Keep this medicine out of the sight and reach of children. Accidental overdose by a child is dangerous and may be fatal.
Do not use any tablets after the expiry date which is stated on the blister and carton or bottle label. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not take your tablets if they are broken or crushed as this can be dangerous and can cause serious problems such as overdose.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Oxeltra tablets contain
The active ingredient is oxycodone hydrochloride. Each tablet contains 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg or 80 mg of oxycodone hydrochloride.
The other ingredients are: lactose monohydrate, hypromellose (E464), povidone, stearic acid, magnesium stearate and anhydrous silica colloidal.
In addition, the tablet coatings contain the following:
5 mg - polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), indigo carmine aluminium lake (E132) and iron oxide yellow (E172).
10 mg - hypromellose (E464), titanium dioxide (E171), macrogol (El521), polysorbate (E433).
15 mg - polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), iron oxide black (E172) and iron oxide yellow (E172).
20 mg - polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b) and iron oxide red (E172).
30 mg - polyvinyl alcohol (E1203), macrogol (E1521), talc (E553b), iron oxide red (E172), iron oxide black (E172) and indigo carmine aluminium lake (E132).
40 mg - polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b) and iron oxide yellow (E172).
60 mg - polyvinyl alcohol (E1203), macrogol (E1521), talc (E553b), iron oxide red (E172), carmine and iron oxide black (E172).
80 mg - polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), indigo carmine aluminium lake (E132) and iron oxide yellow (E172).
What Oxeltra tablets look like and the contents of the pack
The tablets are marked OX along with the strength (5, 10, etc) on one side. All strengths are round, bi-convex, film coated tablets.
The tablets are all film coated in the following colours:
5 mg - blue, 10 mg - white, 15 mg - grey, 20 mg - pink,
30 mg - brown, 40 mg - yellow, 60 mg - red, 80 mg - green.
Oxeltra 5mg Tablets are available in cartons containing 28 or 100 tablets.
Oxeltra 10mg, 15mg, 20mg, 30mg, 40mg, 60mg and 80mg ■ Tablets are available in cartons containing 56 or 100 tablets.
Not all pack sizes may be marketed. ;
Marketing Authorisation Holder and Manufacturer ,
Marketing Authorisation Holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK Ma nufacturer
CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only).
Please be ready to give the following information:
|
Product name |
Reference number |
|
Oxeltra 5mg Prolonged-Release Tablets |
PL 29831/0630 |
|
Oxeltra 10mg Prolonged-Release Tablets |
PL 29831/0631 |
|
Oxeltra 15mg Prolonged-Release Tablets |
PL 29831/0632 |
|
Oxeltra 20mg Prolonged-Release Tablets |
PL 29831/0633 |
|
Oxeltra 30mg Prolonged-Release Tablets |
PL 29831/0634 |
|
Oxeltra 40mg Prolonged-Release Tablets |
PL 29831/0635 |
|
Oxeltra 60mg Prolonged-Release Tablets |
PL 29831/0636 |
|
Oxeltra 80mg Prolonged-Release Tablets |
PL 29831/0637 |
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in 08/2016